New Ischemic Cerebral Lesions After Endarterectomy vs. Stenting for the Treatment of Symptomatic Carotid Stenosis (CARECarotid)
Primary Purpose
Carotid Artery Stenosis, Carotid Atherosclerosis, Stroke, Ischemic
Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Carotid Artery Stenting
Endarterectomy carotid artery
Sponsored by
About this trial
This is an interventional treatment trial for Carotid Artery Stenosis focused on measuring carotid angioplaty, MRI DWI
Eligibility Criteria
Inclusion criteria comprised:
- patient's age ≥ 18 years;
- 60-99% stenosis of the internal carotid artery (degree of stenosis assessed by means of Doppler sonography, CT angiography or catheter angiography);
- diameter of the target internal carotid artery not more than 7 mm;
- symptomatic lesion (a history of ipsilateral stroke, transient ischaemic attack or reversible ischaemic neurological deficit);
- localisation and morphology of the lesion making possible surgical eversion endarterectomy or endovascular angioplasty with stent implantation;
- written informed consent.
Exclusion criteria comprised:
- target lesion that has been previously stented;
- highly calcified lesions;
- very tortuous common and internal carotid arteries;
- occlusion of the contralateral carotid artery without adequate collateral circulation through the circle of Willis (revealed by means of transcranial Doppler sonography);
- anatomical contraindications for eversion endarterectomy;
- acute ipsilateral stroke;
- disabling stroke at any side;
- other severe pathologies of the brain resulting is significant loss of cerebral tissue and/or significant neurological deficits, such as extensive previous stroke or multiple lacunar infarcts;
- history of haemorrhagic transformation of ischaemic stroke;
- severe comorbidities (such as cancer or decompensated heart failure);
- allergy to aspirin, clopidogrel or ticlopidine;
- allergy to iodinated contrast media;
- pregnant women;
- women of reproductive age who do not use effective contraception;
- metallic implants (such as peacemakers and orthopaedic endoprostheses) or other known contraindications for magnetic resonance imaging;
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Carotid Artery Stenting
Endarterectomy carotid artery
Arm Description
Subjects will undergo carotid artery angioplasty and stenting with any CE-certificated carotid stent with a proximal protection system Mo.Ma
Subjects will undergo carotid endarterectomy
Outcomes
Primary Outcome Measures
The purpose of this study is to compare the rate of new ischemic brain injury detectable on MRI after carotid artery stenting and endarterectomy.
Number of patients with treatment related new ipsilateral cerebral embolic lesions in brain diffusion-weighted magnetic resonance imaging within 2-4 days post carotid artery stenting and endarterectomy. Number, size and location new cerebral lesions per patients in both groups.
Secondary Outcome Measures
Any Stroke, TIA, MI or death
Number of patients with occurrence of any stroke, transient ischemic attack (TIA), myocardial infarction, or death within 6 months after carotid artery stenting and endarterectomy.
Full Information
NCT ID
NCT03764306
First Posted
November 29, 2018
Last Updated
December 3, 2018
Sponsor
Jagiellonian University
1. Study Identification
Unique Protocol Identification Number
NCT03764306
Brief Title
New Ischemic Cerebral Lesions After Endarterectomy vs. Stenting for the Treatment of Symptomatic Carotid Stenosis
Acronym
CARECarotid
Official Title
New Ischemic Cerebral Lesions Revealed by the Imaging Magnetic Resonance Imaging After Endarterectomy vs. Stenting Under Proximal Protection for the Treatment of Symptomatic Carotid Stenosis: Results of a Randomised Prospective Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Terminated
Why Stopped
Problem with recruitment of patients meeting the inclusion criteria.
Study Start Date
May 1, 2015 (Actual)
Primary Completion Date
May 1, 2015 (Actual)
Study Completion Date
October 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jagiellonian University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Background and purpose. Even if periprocedural cerebral microembolism associated with carotid endarterectomy or stenting usually does not manifest as clinically overt stroke, neuropsychological disturbances resulting from these events represent an important clinical and socioeconomic problem. Still, it remains unclear whether the use proximal protection can lower the incidence of cerebral embolism associated with the treatment of carotid stenosis.
Materials and methods. This was a prospective randomised single-centre study, which was aimed at comparison of surgical eversion endarterectomy with stenting under proximal protection in symptomatic patients. The investigators evaluated the incidence of new ischaemic lesions revealed by the diffusion-weighted magnetic resonance imaging 2-4 days after the treatment and neurologic events.
Detailed Description
The CARECarotid was a prospective randomised single-centre study, which was performed in the University Hospital in Kraków. It was planned to evaluate 50 patients presenting with symptomatic lesions of the internal carotid artery.
Patients were randomly assigned to one of the two treatment arms: surgical endarterectomy or carotid angioplasty with stenting under proximal protection. All patients provided their written informed consent to undergo the procedures and to participate in this trial.
In all surgical patients carotid endarterectomy will perform using the eversion technique. All surgical endarterectomies will perform under cervical block anaesthesia.
Perioperatively patients in the surgical arm received aspirin; other antiplatelet or anticoagulant agents were not administered during 5 days before surgery.
All procedures in carotid artery stenting will perform with proximal protection system - the Mo.Ma (Medtronic, Minneapolis, MN, USA) device. The investigators will implante stents that were tailored to the localisation of lesions and morphology of carotid arteries: Carotid Wallstent (Boston Scientific, Natick, MA, USA, and in patients with tortuous arteries Precise Pro RX (Cordis, Fremont, CA, USA) or Roadsaver (Terumo, Tokyo, Japan). Patients in the stent arm will receive clopidogrel 75 mg/day and aspirin 75 mg/day. These drugs were administered during 3 days before planned procedure and then 3-6 months after stent implantation. All patients will have MRI DWI performed before and 2-4 days after procedures in both groups. Within 6 months there will be an evaluation of the incidence of neurological events.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Artery Stenosis, Carotid Atherosclerosis, Stroke, Ischemic
Keywords
carotid angioplaty, MRI DWI
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients were randomly assigned to one of the two treatment arms: surgical endarterectomy or carotid angioplasty with stenting under proximal protection
Masking
Investigator
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Carotid Artery Stenting
Arm Type
Active Comparator
Arm Description
Subjects will undergo carotid artery angioplasty and stenting with any CE-certificated carotid stent with a proximal protection system Mo.Ma
Arm Title
Endarterectomy carotid artery
Arm Type
Active Comparator
Arm Description
Subjects will undergo carotid endarterectomy
Intervention Type
Procedure
Intervention Name(s)
Carotid Artery Stenting
Intervention Description
Carotid artery stenting was considered successful if there was no residual stenosis greater than 20%, and there was no dissection of target artery following the procedure.
Intervention Type
Procedure
Intervention Name(s)
Endarterectomy carotid artery
Intervention Description
Surgical endarterectomy was considered successful if there was no residual stenosis after procedure, without symptoms.
Primary Outcome Measure Information:
Title
The purpose of this study is to compare the rate of new ischemic brain injury detectable on MRI after carotid artery stenting and endarterectomy.
Description
Number of patients with treatment related new ipsilateral cerebral embolic lesions in brain diffusion-weighted magnetic resonance imaging within 2-4 days post carotid artery stenting and endarterectomy. Number, size and location new cerebral lesions per patients in both groups.
Time Frame
2-4 days after procedure
Secondary Outcome Measure Information:
Title
Any Stroke, TIA, MI or death
Description
Number of patients with occurrence of any stroke, transient ischemic attack (TIA), myocardial infarction, or death within 6 months after carotid artery stenting and endarterectomy.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria comprised:
patient's age ≥ 18 years;
60-99% stenosis of the internal carotid artery (degree of stenosis assessed by means of Doppler sonography, CT angiography or catheter angiography);
diameter of the target internal carotid artery not more than 7 mm;
symptomatic lesion (a history of ipsilateral stroke, transient ischaemic attack or reversible ischaemic neurological deficit);
localisation and morphology of the lesion making possible surgical eversion endarterectomy or endovascular angioplasty with stent implantation;
written informed consent.
Exclusion criteria comprised:
target lesion that has been previously stented;
highly calcified lesions;
very tortuous common and internal carotid arteries;
occlusion of the contralateral carotid artery without adequate collateral circulation through the circle of Willis (revealed by means of transcranial Doppler sonography);
anatomical contraindications for eversion endarterectomy;
acute ipsilateral stroke;
disabling stroke at any side;
other severe pathologies of the brain resulting is significant loss of cerebral tissue and/or significant neurological deficits, such as extensive previous stroke or multiple lacunar infarcts;
history of haemorrhagic transformation of ischaemic stroke;
severe comorbidities (such as cancer or decompensated heart failure);
allergy to aspirin, clopidogrel or ticlopidine;
allergy to iodinated contrast media;
pregnant women;
women of reproductive age who do not use effective contraception;
metallic implants (such as peacemakers and orthopaedic endoprostheses) or other known contraindications for magnetic resonance imaging;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pawel Latacz, PhD MD
Organizational Affiliation
Jagiellonian University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
20142180
Citation
Cremonesi A, Gieowarsingh S, Spagnolo B, Manetti R, Liso A, Furgieri A, Barattoni MC, Ghetti L, Tavazzi L, Castriota F. Safety, efficacy and long-term durability of endovascular therapy for carotid artery disease: the tailored-Carotid Artery Stenting Experience of a single high-volume centre (tailored-CASE Registry). EuroIntervention. 2009 Nov;5(5):589-98. doi: 10.4244/eijv5i5a95.
Results Reference
result
PubMed Identifier
20222019
Citation
Ansel GM, Hopkins LN, Jaff MR, Rubino P, Bacharach JM, Scheinert D, Myla S, Das T, Cremonesi A; Investigators for the ARMOUR Pivotal Trial. Safety and effectiveness of the INVATEC MO.MA proximal cerebral protection device during carotid artery stenting: results from the ARMOUR pivotal trial. Catheter Cardiovasc Interv. 2010 Jul 1;76(1):1-8. doi: 10.1002/ccd.22439.
Results Reference
result
PubMed Identifier
22454248
Citation
Bersin RM, Stabile E, Ansel GM, Clair DG, Cremonesi A, Hopkins LN, Nikas D, Reimers B, Sievert H, Rubino P. A meta-analysis of proximal occlusion device outcomes in carotid artery stenting. Catheter Cardiovasc Interv. 2012 Dec 1;80(7):1072-8. doi: 10.1002/ccd.24433. Epub 2012 Jul 23.
Results Reference
result
PubMed Identifier
10942686
Citation
Gao MY, Sillesen HH, Lorentzen JE, Schroeder TV. Eversion carotid endarterectomy generates fewer microemboli than standard carotid endarterectomy. Eur J Vasc Endovasc Surg. 2000 Aug;20(2):153-7. doi: 10.1053/ejvs.1999.1072.
Results Reference
result
PubMed Identifier
21307169
Citation
Silver FL, Mackey A, Clark WM, Brooks W, Timaran CH, Chiu D, Goldstein LB, Meschia JF, Ferguson RD, Moore WS, Howard G, Brott TG; CREST Investigators. Safety of stenting and endarterectomy by symptomatic status in the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST). Stroke. 2011 Mar;42(3):675-80. doi: 10.1161/STROKEAHA.110.610212. Epub 2011 Feb 9.
Results Reference
result
Learn more about this trial
New Ischemic Cerebral Lesions After Endarterectomy vs. Stenting for the Treatment of Symptomatic Carotid Stenosis
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